With more than two million page views and more than 4,500 items, this blog provides news and commentary on public policy, business and economic issues related to the $3 billion California stem cell agency, officially known as the California Institute for Regenerative Medicine(CIRM). David Jensen, a retired California newsman, has published this blog since January 2005. His email address is djensen@californiastemcellreport.com.

Tuesday, March 24, 2015

From cash
payments to conflicts of interest, the $3 billion California stem cell agency this
week is set to ratify a radical change in how it awards its largess and
oversees the research it funds.

Coming up
for approval today by a key panel of the agency’s directors are new rules
governing how scientists apply for millions of dollars and how they will
receive payments.

Instead of
checks rolling in primarily on a calendar basis, for example, they will reach
researchers only if they meet milestones approved by the agency, formally known
as the California Institute for Regenerative Medicine (CIRM).

The proposals
are part of CIRM 2.0, a label coined by UC Davis researcher Paul Knoepfler and
adopted by Randy Mills, who has been president of the agency since last May.

With CIRM
2.0, Mills hopes to generate faster and better results than in the past. The
main, direct impact will fall on the hundreds of California researchers who will
have future agency funding. But if Mills is successful, it will also pay off for
California citizens who are financing the agency with borrowed money at a total
cost of $6 billion including interest.

The rules
will apply immediately only to three clinical stage rounds, but Mills expects to
extend them to all future rounds. Officially they are called interim and are
subject to additional vetting through the state’s official rule-making process.

Here is a
brief look at some of the key features of the new rules, based on a memo prepared by Mills and his team. The rules were first considered in January but
final approval was put off until this month.

Payments:
Made only on completion of successful milestones. A CIRM memo said, “Additionally,
in many circumstances the grantee will be allowed to keep unspent CIRM funds
upon successful completion of the project, to be spent on any other project of
the grantee’s that is consistent with advancing CIRM’s mission. This new
process will incentivize grantees to advance the project in the most efficient
and shortest time possible, fulfilling CIRM’s goal to accelerate such projects.”

Background
check: Applicants will “undergo a background check to ensure no prior or
pending records of fraud or misuse of funds”

External
budget review: As soon as an application is received, it will scrutinized by an
external contractor “to identify where proposed costs diverge from established
market rates and where opportunities for budget tightening may be found.” This is
in addition to budget reviews by staff, the grant review group and the board.

Severe
appeal restrictions: Appeals by applicants will be
restricted to “a demonstrable financial, professional, or personal conflict of
interest, as defined in the (agency’s) conflict of interest policy, (that) had
a negative impact on the review process and resulted in a flawed review.
Differences of scientific opinion between or among PIs (principal
investigators) and reviewers are not grounds for appeal.” State law, however,
permits researchers to communicate directly with the CIRM board on any matter.
It is almost impossible for applicants to identify conflicts of interests
because the names of persons who review their applications are withheld by the
agency. Plus reviewers’ professional and financial interests are withheld by the agency.

Clinical
advisory panels (CAPs): These new panels “will provide real-time course
correction and will focus more on acceleration opportunities than pure
evaluation. CAPs will be tailored for the needs of each project and will
consist of CIRM and external members, more nimbly sized than prior (advisory) panels. CAPs
will meet on a quarterly basis (instead of annually…) and examine all relevant
information regarding project progression, possible roadblocks and avenues for
progression.”

Elimination
of documentation: Instead of requiring awardees to produce many documents, the
agency “will rely on certification of compliance by the applicant, with the
ability for CIRM to request supporting documentation if cause to do so arises”

The proposed
rules are expected to be approved today at the 2:30 p.m. PDT meeting of the Science Subcommittee of the CIRM
board and ratified on Thursday by the full board at its meeting in Berkeley. The public can address the subcommittee at meeting locations in Washington, D.C., two in the Los Angeles area and one each in San Francisco, San Jose, Irvine, Oakland and La Jolla. Specific addresses can be found on the agenda.

David- I was surprised by the new requirement for PIs to "undergo a background check to ensure no prior or pending records of fraud or misuse of funds".What bothers me about this is that there must be some reason to fear that some of us are frauds…has CIRM identified people like this is the past??

About Me

The California Stem Cell Report is the only nongovernmental website devoted solely to the $3 billion California stem cell agency. The report is published by David Jensen, who worked for 22 years for The Sacramento Bee in a variety of editing positions, including executive business editor and special projects editor. He was the primary editor on the 1992 Pulitzer Prize-winning series, "The Monkey Wars" by Deborah Blum, which dealt with opposition to research on primates. Jensen served as a press aide in the 1974 campaign and first administration of Gov. Jerry Brown. (Time served: two years and one week.) He writes from his sailboat on the west coast of Mexico with occasional visits to land. Jensen began writing about the stem cell agency in 2005, noting that it is an unprecedented effort that uniquely combines big science, big business, big academia, big politics, religion, ethics and morality as well as life and death. The California Stem Cell Report has been identified as one of the best stem cell sites on the Internet. Its readership includes the media (both mainstream and science), a wide range of academic/research institutions globally, the NIH and California policy makers.